FWIW, the 10K still maintains expectations for this year. But I'm not holding my breath :)

I'm looking forward to the 10K (after hours?), hopefully we get more information hidden in there. The call was not really insightful.

One thing's clear, the market does not trust Anavex/Missling. Rett is now in doubt for 2023. Let's see if he can deliver on time.

(Below is just speculation for fun, not to be taken seriously)

I wonder about the timing of this PR. There's nothing material in there, so Anavex chose to release this info as opposed to having to.

Why do it ahead of Rett results? It's fun to speculate sometimes, and I'm sure we can have folks come up with both the most bullish and bearish of reasons!

Interesting news this morning. Assuming this has a good chance of being successful, we must be in negotiations with a partner a we don't have the capacity to service such a large area by ourselves.

Looking forward to hopefully more positive news in the weeks to come.

I'm no expert, but I found this.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4231465/#:~:text=The%20McGill%2DR%2DThy1%2D,control%20of%20the%20murine%20Thy1.

I get it, but also irrelevant. They're not mutually exclusive. The rest will come, and that was made clear in the PR (I would have been more worried if that was not the case).

Vaccines are one of the best advancements in medicine (up there with penicillin) and this whole anti-vax movement is costing lives. Unfortunate that folks would believe random stuff instead of following data.

That's not true at all. Plenty of so-so (or even mediocre) results get published. That's how science/research advances.

Let's wait and see the results.

Anavex doesn't control the timelines/release of scientific articles. So are you expecting them not to PR them? I sure don't agree with that.

There's nothing more or less to read into this PR as good pre-clinical results for 3-71.

There's nothing ambiguous about this PR. I'd be the first to highlight it if there was any.

If you read the paragraph, the order makes sense as Alz is more relevant to the PR and makes the flow better. I wouldn't read into it more than that.

I get that emotions are high because of the SP, but there's absolutely nothing wrong with this PR. I found it clear and concise and it's excellent to see more 3rd party pre-clinical validation of our drugs/platform (McGill is top-3 Canadian university). Obviously positive pre-clinical results is no guarantee, but it does increase the confidence (and one of the reasons I decided to invest in AVXL).

And the PR reiterates the 2 events we're waiting for (Rett TLR & Alz article). We'll get the Rett TLR in the next few weeks, very much looking forward to them.

I have slightly higher odds for AA but otherwise agree with this assessment.

I'm starting to think that we'll partner up for that P3. We can't keep going at this pace.

All in all, when you take the plethora of pre-clinical and clinical data we currently have, I'm pretty confident that Blarcamesine is therapteuric. We just need that confirmatory trial to settle this once and for all, no buts and ifs. And no more dose dependency, just 2 arms, active and placebo.

With that said, this will most probably be my last post until the next major news we get (Rett TLR most probably). Thanks everyone for the productive discussions.

Except I doubt it was his call lol

Dr. Jin won't do that, it wouldn't be ethical. But he'll definitely know exactly how to present the data in a positive way.

Hiring him is probably the best move CM has done this year.

That's sounds like a good recap of the 2 potential outcomes wrt approval and the FDA.

Thanks!

With that in mind, curious why you think AA has a very low possiblity?

On paper, we seem to check all the boxes. The only thing that makes me hesitate is if the FDA will accept the biomarkers as proof of clinical evidence. I have no idea, it's not my field.

Curious what you define as "near-term"? I'm assuming that any shot of AA will need to have the confirmatory trial well underway.

The MRI is intriguing with it's very low p value. So fingers crossed this convinces the FDA.

I think the big difference is that cancer has clearer biomarkers than Alzheimer's.

But I would love to know more from knowledgeable folks such as Doc.

In cancer, this is clearly way more prevalent. Let's hope the FDA applies the same rules for CNS.

That example is for AA, not full approval.

If anything this validates even more my thinking. Thanks for sharing!

I have to disagree with this. You should aim to treat it as a P3 as this is the worst case scenario.

BTD is a given IMO with the data we've seen. But I still hope we get AA, and get this drug to patients earlier.

And either way, it should be easy to attract good partners and get a good deal with that data.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

You really need to read up on drug development, trials and phases. And I don't say that to be mean, it's important.

Confirmatory trials have no margin of error, they need to hit their pre-specified endpoints or else they are a failure. It'll be rare that such trials still get approval (mostly for rare diseases).

As for non confirmatory trials, the definition of a failure is way looser. Not hitting your endpoints is not fatal if you're able to gather enough positive data to design the next one (that can potentially be confirmatory). Examples include subgroup analysis.

This is what we have here. I'm not saying the trial is a failure. But it failed to meet the co-primary endpoints for the means measurement. So I really don't see how the FDA can approve it as is, it would be lowering the bar. I know Anavex has an alternate defition of success, and it's intriguing but I have not seen any precedence for it.

You really need to go and reread December's PR and listen to the CC.

The claim of endpoint met was based on the OR measurement, which was pre-specified in the SAP.i have no problem with that. But it's not random that the latest PR makes no mention of OR and focuses only on the means.

The company is telling something, you really need to listen to it.

I think you're having trouble following the conversation. Just go reread to understand that I never said the company lied. But that meeting the OR measurement will not give you FDA approval. You need to meet the means. And that one, unfortunately, they didn't.

Or the markets are completely miscalculating this.

We'll find out soon enough.

If your odds are 25%, then the SP is way undervalued here. No way our MC is only at 2-2.5B with AA for AD. And that's not even counting the other indications and potential for full AD approval even without AA.

We're on the same page and only logical explanation is that Anavex will apply for AA, which has a lower bar and this + biomarkers might very well convince the FDA.

So you think Anavex is hiding a stat Sig measurement on purpose? Because if so, then that's a huge issue.

There's basically no valid scenario under which I can see the company withholding that value, except if it's not stat Sig.

https://en.m.wikipedia.org/wiki/Deductive_reasoning

To be fair, you're better off taking your time to analyze the current trial so you start a new one that has the highest chance of success. Which is what I think Anavex is doing.

From the look of it, hey redid all the analysis in house, so that would explain the delay IMO. I'm perfectly fine waiting longer if that maximizes our chances. In AD, we probably have one last shot so make it count!

That's not my issue at all. The problem is you can't have endpoints pre-specified and then change them post hoc. That's a no no in research. Otherwise it becomes too easy.

So I go back to my assertion that we had 2 co-primary endpoints and they were not met per the strict definition. So AA it is (hopefully we get it).

I'm not in the medical field so I can't assert to what actual endpoints are most meaningful. I'm strictly speaking about the protocol and how companies have to follow what's pre-specified in the SAP.

And you'll never hear me utter any of these words. We have an intriguing drug that is mostly safe (no dispute there) and seems to be therapeutic (still not fully proven yet).

Thanks for sharing, that's exactly what I expect our next move is for Alz.

Shush, adults are talking. Go back to your playground.

But that's often the case with biotechs. Look, I think I've made my position clear that I don't like the subpar comms. But at the end of the day, the plan hasn't changed much and we still have Rett to look forward to.

Genuine question: why are people freaking out about the price? If there's one thing that CM has done a tremendous job at, it's the finances. Our runway is strong so there's no pressure at all to raise money at these levels.

Often biotechs are poorly financed and raising money at lower SP just lowers it more and spirals. This will not be our case here. Our SP only depends on data and execution in the short term. And I'm cautiously optimistic about those, although obviously still a very risky investment.